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+496131 276 791 0

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API Thinking GmbH
Mombacher Straße 68
55122 Mainz

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Our services include:

Consulting

“Nothing is more constant than change.”

Digital transformation has finally arrived in laboratories. In the smart labs of the future, instruments, processes and data will be seamlessly networked, automatically analyzed and controlled by intelligent applications.

Maximizing the value of these developments and mapping individual laboratory requirements in future scenarios call for experts who combine a deep understanding of future-oriented technologies and science. ApiThinking has consistently specialized in this area, assembling a team of professionals from both of these "worlds". We analyze how to transfer individual workflows into automated processes and how to optimally integrate existing laboratory information management systems (LIMS). The goal is to make your lab processes more efficient and secure while fulfilling the applicable compliance requirements.

In consulting as well, we pursue a holistic approach and offer an extensive service portfolio that ranges from consulting on system and process analyses to support for change management and system selection and qualification. If you wish, we can accompany you throughout your entire project.

In today's pharmaceutical industry, IT projects are an increasingly important step on the way to a digital world. Our approach is always centered on your goals and the realization of your project, although our perspective is different from yours. We are with you all the way – transparently, authentically and with passion.

We give new impulses and react flexibly to changes, because our experts have already experienced all roles in an IT project themselves and have the expertise for the possible complexity without losing sight of the big picture. Together with you, we want to walk this path and be part of the new world.

ProjeCtmanagement

External project management to facilitate and standardize of your IT projects.

LABOR-IT / Lims-Services

We support you with experts in interface technology and data processing

ApiThinking supports your laboratories in replacing manual, paper-based processes, working with you to develop solutions according to your specific requirements. Whether for R&D, QA or production – we support you in evaluating suitable solutions and processes in both regulated and non-regulated environments.

Our experts support you in determining your requirements, accompany vendor selection as well as entire implementation processes including decommissioning of your legacy systems. We provide expert services for upgrade and change projects as well as for the integration of new instruments and systems.

In this context, we focus keenly on integration and networking of your existing laboratory landscape. MES, LES, ELN or LIMS systems have been developed specifically for mapping the respective issues and provide valuable insights into specified subareas. But to generate maximum benefit, these individual solutions must increasingly interact with each other in the future to ensure data integrity and compliance as well as data insights across all laboratory processes.

ApiThinking supports you with experts in interface technology and data processing. We see it as our task to maximize the interoperability of your individual labs to ensure the greatest possible benefit for you.

In the context of "smart lab" developments and the increasing networking of a wide variety of laboratory systems, we can expect massive amounts of data to accrue. Laboratories of the future will become data factories, with optimum data exploitation becoming increasingly important for innovative companies.

KNOWLEDGE IS KEY: With the help of data insights and evidence-based decisions, you can increase the productivity of your labs, optimize your performance and build a long-term business and digitalization strategy.

ApiThinking supports you with comprehensive data insight and data analysis services, targeted for the evaluation and analysis of all lab-relevant data. The goal is to bring together and process data from a wide variety of systems for maximum usefulness in making data-based quality- and company-relevant decisions.

DATA INSIGHTS/ DATA ANALYSIS

Increase lab productivity with data insights and evidence-based decisions.

Development Services

Individual processes call for individual solutions.

Our development team offers you innovative solutions for mapping your specific requirements to replace manual, paper-based processes in your lab operations.

We develop software modules, databases and interfaces individually for you to enhance the quality, security and compliance of your laboratory processes.

After an initial analysis of your needs and existing lab processes, we define detailed requirements for the implementation of measures to be carried out by our development team. In addition, we provide the corresponding documentation and support the system throughout its lifecycle.

For companies working under GxP requirements, regulatory compliance is critical.

Especially in the GMP area, deployed computer systems must be validated to document that the systems function in compliance with regulations defined under FDA 21 CFR Part 11, EU GMP Annex 11 and Annex 15.

ApiThinking supports you in the execution of all planned computer system validation activities, from the conceptual design phase to the development of the validation master plan.

If required, our experts will take over project management, support change management and prepare the required validation documentation. We validate based on your instructions, specifically focusing on a best-practice and risk-based approach while complying with the required specifications.

Computer System Validation

From concept to full development of your validation master plan.

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